European Medicines Agency [to 4 June 2016]
http://www.ema.europa.eu/

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03/06/2016
Regulation of advanced therapy medicines
Report details concrete proposals to encourage development and authorisation of advanced therapy medicinal products (ATMPs) in the EU
The European Medicines Agency (EMA) today published a report from a multi-stakeholder expert meeting held on 27 May 2016 to explore possible ways to foster the development of ATMPs in Europe and expand patients’ access to these new treatments.

ATMPs comprise gene therapies, tissue engineered products and somatic cell therapies. These medicines have the potential to reshape the treatment of a wide range of conditions, particularly in disease areas where conventional approaches are inadequate. However, eight years since EU legislation on ATMPs entered into force in 2008, only five ATMPs are currently authorised. At the same time clinical trials investigating ATMPs appear to represent a fast-growing field of interest, underlining the need to better support innovation through a coherent and appropriate regulatory environment.

“We have organised this meeting with all relevant stakeholders to discuss concrete proposals on how we can nurture a regulatory environment that encourages development of ATMPs, safeguards public health and, ultimately, facilitates timely access for patients to much needed treatments,” said EMA’s Executive Director Guido Rasi in his opening address…

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01/06/2016
First statistics on PRIME are released
Four medicines in development are accepted under the scheme
The European Medicines Agency (EMA) has released today the outcome of the assessment of the first batch of applications received from medicine developers for its PRIME (PRIority MEdicines) scheme, a new initiative that aims to foster research on and development of medicines that have the potential to address an unmet medical need.

18 applications for PRIME were received as of 6 April 2016 and subsequently assessed by EMA’s Scientific Advice Working Party, Committee for Advanced therapies (CAT) and Committee for Medicinal Products for Human Use (CHMP). Four medicines have been accepted for PRIME.

EMA is making available detailed information on the applications that have been granted or denied access to PRIME, including statistics on the type of applicants, the therapeutic areas represented and the data supporting the applications…